Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

FDA Comment Number :

EC12

Submitter :

Ms. Shayna Norman

Date & Time:

12/09/2005 04:12:45

Organization :

Ms. Shayna Norman

Category :

Health Professional

Issue Areas/Comments

GENERAL

GENERAL

As a concerned citizen as well as a health professional, I am angered by Senator Colburn's attempts to change the FDA label on condoms to suggest that they are less effective against preventing pregnancy and preventing STI transmission than is currently stated.
From the CDC's website the following data can be easily obtained demonstrating the efficacy of condoms:
'Laboratory studies have demonstrated that latex condoms provide an essentially impermeable barrier to particles the size of STD pathogens.
Sexually transmitted diseases, including HIV Latex condoms, when used consistently and correctly, are highly effective in preventing transmission of HIV, the virus that causes AIDS. In addition, correct and consistent use of latex condoms can reduce the risk of other sexually transmitted diseases (STDs), including discharge and genital ulcer diseases. While the effect of condoms in preventing human papillomavirus (HPV) infection is unknown, condom use has been associated with a lower rate of cervical cancer, an HPV-associated disease.'
It is disturbing that the FDA would allow social conservative politics, or any politics at all, to influence FDA policy and guidelines. This demonstrates a serious lack of commitment to the health and safety of all Americans. Scientific fact and evidence-based medicine should be the only influence the FDA heeds when making decisions. The FDA would be misleading and misinforming millions of Americans if the label is changed to reflect Sen. Colburn's socially conservative agenda. The FDA cannot put the health and lives of millions of Americans at risk. The fact that the FDA is even considering a label change demonstrates a serious failure to prioritize the health and safety of Americans over politics.